Part 10 Transitional provision in respect of pharmacovigilanceF1

1. 58Referrals made under Article 107i of the 2001 Directive concerning the evaluation of data from pharmacovigilance activities which are not concluded before IP completion day
2. 59Matters on-going at IP completion day in respect of periodic safety update reports
3. 60Matters on-going at IP completion day in relation to draft study protocols under Article 107n and 107o of the 2001 Directive (submission of, and amendment to, draft study protocols for required studies)
4. 61Matters on-going at IP completion day in respect of the follow up of final study reports